Trial · NCT02318784
Carfilzomib for the Treatment of Patients With Advanced Neuroendocrine Cancers
NCT02318784, Phase 2, Completed, SCRI Development Innovations, LLC; results first posted 2022-07-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Carfilzomib for the Treatment of Patients With Advanced Neuroendocrine Cancers. Trials, record NCT02318784. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02318784
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Carfilzomib for the Treatment of Patients With Advanced Neuroendocrine Cancers
- NCT number
- NCT02318784
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 62 participants, actual
- Lead sponsor
- SCRI Development Innovations, LLC
- Conditions
- Neuroendocrine Cancer
- Interventions
- Carfilzomib
- First posted
- 2014-12-17
- Last updated
- 2023-12-05
- Results first posted
- 2022-07-01
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) | every 3 cycles (1 cycle= 28 days) until treatment discontinuation up to 4 years | Percentage of participants with confirmed complete response (CR) or partial response (PR) (i.e. 2 CRs or PRs at least 4 weeks apart) to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) CR=disappearance of all target lesions. PR=at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Disease Control Rate (DCR) | every 3 cycles (1 cycle= 28 days) until treatment discontinuation up to 4 years | Percentage of participants with complete response (CR), partial response (PR), or stable disease (SD) (≥ 6 cycles) according to RECIST v1.1 criteria. Complete Response is defined per RECIST as the disappearance of all target/non-target lesions and normalization of tumor markers. Partial Response is defined per RECIST as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Stable disease is defined per RECIST as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest (nadir) sum LD since the treatment started. |
| Secondary | Progression Free Survival (PFS) | up to 4 years | Measured from Day 1 of study drug administration to disease progression as defined by RECIST v1.1, or death on the study. Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or unequivocal progression of non-target lesions or the appearance of one or more new lesions. Patients who did not have disease progression or death documented were censored on the date of the last visit with adequate assessment. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability | From the day of the first dose to 30 days after the last dose of study medication, up to 4 years | The number of treatment-emergent adverse events will be graded utilizing the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (ORR) | every 3 cycles (1 cycle= 28 days) until treatment discontinuation up to 4 years | All enrolled patients who received at least one full or partial dose of the study drug and who had measurable disease at baseline were included in the analysis. | percentage of participants | NUMBER |
| SECONDARY | Disease Control Rate (DCR) | every 3 cycles (1 cycle= 28 days) until treatment discontinuation up to 4 years | All enrolled patients who received at least one full or partial dose of the study drug and who had measurable disease at baseline were included in the analysis. | percentage of participants | NUMBER |
| SECONDARY | Progression Free Survival (PFS) | up to 4 years | All enrolled patients who received at least one full or partial dose of the study drug and who had measurable disease at baseline were included in the analysis. | months | MEDIAN |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability | From the day of the first dose to 30 days after the last dose of study medication, up to 4 years | All enrolled patients who received at least one full or partial dose of the study drug. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (ORR) | Carfilzomib | 3.226 | 95% Confidence Interval 0.4 to 11.2 | percentage of participants | |
| Disease Control Rate (DCR) | Carfilzomib | 58 | 95% Confidence Interval 44.8 to 70.5 | percentage of participants | |
| Progression Free Survival (PFS) | Carfilzomib | 8 | 95% Confidence Interval 2.9 to 11.1 | months | |
| Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability | Carfilzomib | 56 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Carfilzomib | 62 | |
| Overall Study | COMPLETED | Carfilzomib | 0 | |
| Overall Study | NOT COMPLETED | Carfilzomib | 62 |
Source ClinicalTrials.gov
Adverse events304
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Carfilzomib | 12 | 62 | 41 |
| other | Increased tendency to bruise | Blood and lymphatic system disorders | Carfilzomib | 1 | 62 | 1 |
| other | Leukocytosis | Blood and lymphatic system disorders | Carfilzomib | 1 | 62 | 1 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Carfilzomib | 1 | 62 | 1 |
| other | Neutropenia | Blood and lymphatic system disorders | Carfilzomib | 1 | 62 | 1 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Carfilzomib | 11 | 62 | 89 |
| other | Acute left ventricular failure | Cardiac disorders | Carfilzomib | 2 | 62 | 2 |
| other | Atrial fibrillation | Cardiac disorders | Carfilzomib | 2 | 62 | 2 |
| other | Palpitations | Cardiac disorders | Carfilzomib | 2 | 62 | 2 |
| other | Ear pruritus | Ear and labyrinth disorders | Carfilzomib | 1 | 62 | 1 |
1 to 10 of 304Source ClinicalTrials.gov
See all 304 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Carfilzomib | 10 | 62 |
| Total, other adverse events | Carfilzomib | 61 | 62 |
| Total, serious adverse events | Carfilzomib | 31 | 62 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02318784
GET https://conductscience.org/api/trials/v1/NCT02318784/events?page=2